Classifications

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  • A61B2218/002—Irrigation

Definitions

• This disclosure relates generally to methods and devices for invasive medical treatment, and specifically to catheters, in particular, irrigated ablation catheters.
• RF ablation for example, a catheter is inserted into the heart and brought into contact with tissue at a target location. RF energy is then applied through electrodes on the catheter in order to create a lesion for the purpose of breaking arrhythmogenic current paths in the tissue.
• RF radiofrequency
• Irrigated catheters are now commonly used in ablation procedures. Irrigation provides many benefits including cooling of the electrode and tissue which prevents overheating of tissue that can otherwise cause the formation of char and coagulum and even steam pops.
• tissue temperature is assessed during an ablation procedure to avoid such adverse occurrences, it is important that the temperature sensed accurately reflects the real temperature of the tissue and not merely the surface temperature of the tissue which can be biased by the cooling irrigation fluid from the catheter.
• deeper tissue contact in general provides more accurate thermal and electrical readings, including improved impedance measurements for purposes including a determination of lesion size.
• an irrigated ablation catheter with a distal end that can better probe tissue without significantly damaging or breaching the tissue, for more accurate measurements, including temperature sensing and impedance measurements.
• Atrial fibrillation is the most common sustained arrhythmia in humans. It affects anywhere from 0.4% to 1% of the general population, and increases in prevalence with age, from ⁇ 1% in young adults to 8% in patients over 80 years of age. Radiofrequency (RF) catheter ablation has provided excellent results for treating many types of supraventricular arrhythmias. Its utility in treating paroxysmal AF has already been established; studies have shown high rates of elimination of the arrhythmia.
• RF ablation with the THERMOCOOL SMARTTOUCH ® SF catheter was associated with elimination of symptomatic atrial arrhythmias in 72.5% of patients at 1 year.
• PV isolation The 2017 HRS/EHRA/ECAS/APHRS/SOLAECE Consensus Statement states that electrical isolation of the pulmonary veins (PVs) from the left atrium is "the cornerstone for most AF ablation procedures.” Creation of transmural, continuous, and durable RF lesions is the objective of PV isolation (PVI).
• Conventional parameters of RF ablation with irrigated catheters involves the delivery of moderate power (20-40W) for a relatively long duration (20-40 seconds) at a contact force range of 10-20 grams. Still, the incidence of acute PV reconnection remains frequent, occurring after PVI at a frequency 15-22%. While the mechanisms underlying PV reconnection are not entirely understood, catheter instability, tissue edema, and reversible non-transmural injury have been suggested as major contributor.
• RF lesion formation results from two thermal heating phases; resistive and conductive heating.
• Resistive heating is highly dependent on RF power immediately creating a hot spot ⁇ 2mm from the tip.
• This resistive heating phase creates a heat source that extends passively to deeper tissue layers during the conductive phase.
• Conductive heating is time dependent, with heat conducted from the hot spot into the deeper layers of the myocardium.
• Modification of the relationship between the resistive and conductive heating phases by increasing the resistive heating phase to deliver immediate heating to the full thickness of the LA tissue circumferential to the PVs, may achieve uniform, transmural lesions. By reducing the conductive heating phase collateral tissue damage could be limited. This can be achieved by delivering a large current for a short duration. Accordingly, there is a desire for an ablation catheter that resolves these and other issues of the art.
• an ablation catheter system for drug refractory symptomatic paroxysmal atrial fibrillation (PAF).
• the system can include an elongated body; an electrode assembly comprising a shell configured with an inner chamber and a wall defining a proximal portion and a distal portion, the wall of the distal portion having at least one aperture; and a micro-element extending through the inner chamber between the proximal portion and the distal portion, the micro-element having a distal end received in the at least one aperture, the distal end being at least coextensive with an outer surface of the wall.
• the system is configured to achieve acute procedural PVI success for all patients of a predetermined patient population suffering from PAF.
• an ablation catheter system for drug refractory symptomatic paroxysmal atrial fibrillation (PAF).
• the system can include an elongated body; an electrode assembly comprising a shell configured with an inner chamber and a wall defining a proximal portion and a distal portion, the wall of the distal portion having at least one aperture; and a micro-element extending through the inner chamber between the proximal portion and the distal portion, the micro-element having a distal end received in the at least one aperture, the distal end being at least coextensive with an outer surface of the wall.
• the system is configured to achieve clinically improved total fluid delivered by the ablation catheter system and via intravenous line during PAF and RF ablation.
• an ablation catheter system for drug refractory symptomatic paroxysmal atrial fibrillation (PAF).
• the system can include an elongated body; an electrode assembly comprising a shell configured with an inner chamber and a wall defining a proximal portion and a distal portion, the wall of the distal portion having at least one aperture; and a micro-element extending through the inner chamber between the proximal portion and the distal portion, the micro-element having a distal end received in the at least one aperture, the distal end being at least coextensive with an outer surface of the wall.
• the system is configured to achieve clinically improved safety and effectiveness resulting in approximately at least 80% less RF ablation time compared to ablation time of a previous clinically approved catheter system for treating PAF.
• an ablation catheter system for drug refractory symptomatic paroxysmal atrial fibrillation (PAF).
• the system can include an elongated body; an electrode assembly comprising a shell configured with an inner chamber and a wall defining a proximal portion and a distal portion, the wall of the distal portion having at least one aperture; a micro-element extending through the inner chamber between the proximal portion and the distal portion, the micro-element having a distal end received in the at least one aperture, the distal end being at least coextensive with an outer surface of the wall; and an irrigation pump configured to deliver, by and through the elongated body, a continuous infusion of approximately 2 milliliters/minute of a treatment solution when not delivering RF energy during RF ablation.
• the system is configured to achieve clinically improved safety and effectiveness for PAF with a contact force between the catheter system and a target site working ranging between approximately 5 - 30 grams.
• an ablation catheter system for drug refractory symptomatic paroxysmal atrial fibrillation (PAF).
• the system can include an elongated body; an electrode assembly comprising a shell configured with an inner chamber and a wall defining a proximal portion and a distal portion, the wall of the distal portion having at least one aperture; a micro-element extending through the inner chamber between the proximal portion and the distal portion, the micro-element having a distal end received in the at least one aperture, the distal end being at least coextensive with an outer surface of the wall; and an irrigation pump configured to deliver, by and through the elongated body, a continuous infusion of approximately 2 milliliters/minute of a treatment solution when not delivering RF energy during RF ablation.
• the system is configured to achieve clinically improved safety and effectiveness for PAF with substantially shorter total procedure, ablation, fluoroscopy, and radiofrequency application times.
• an ablation catheter system for drug refractory symptomatic paroxysmal atrial fibrillation (PAF).
• the system can include an elongated body; an electrode assembly comprising a shell configured with an inner chamber and a wall defining a proximal portion and a distal portion, the wall of the distal portion having at least one aperture; a micro-element extending through the inner chamber between the proximal portion and the distal portion, the micro-element having a distal end received in the at least one aperture, the distal end being at least coextensive with an outer surface of the wall; and an irrigation pump configured to deliver, by and through the elongated body, a continuous infusion of approximately 2 milliliters/minute of a treatment solution when not delivering RF energy during RF ablation.
• the system is configured to achieve zero incidence of steam pop occurrence in both left and right atrial ablations using the ablation catheter system at a predetermined irrigation fluid rate and power setting that includes 90W.
• the system is configured to clinically improve treatment of complex cardiac arrhythmias.
• the predetermined patient population size is at least about 50 patients.
• the system includes an irrigation pump for delivering a treatment solution through the catheter system to the treatment site.
• the system includes a force sensory system for detecting contact force applied by the catheter system to the treatment site during use.
• the system is configured only for use in the ablation procedure with irrigation flow and maintaining a flow rate of 8 milliliters/minute.
• clinical safety is determined by proportion of subjects with any primary adverse event (PAE) occurring within 7 days of ablation procedure.
• PAE primary adverse event
• a clinical effectiveness endpoint is determined by proportion of subjects that are free from documented atrial arrhythmia (atrial fibrillation (AF) episodes at Month 12 for at least about 9 months following the ablation procedure.
• AF atrial fibrillation
• a clinical effectiveness endpoint is determined by proportion of subjects that are free from documented atrial tachycardia (AT) episodes at Month 12 for at least about 9 months following the ablation procedure.
• AT atrial tachycardia
• a clinical effectiveness endpoint is determined by proportion of subjects that are free from documented atrial flutter (AFL)) episodes at Month 12 for at least about 9 months following the ablation procedure.
• clinical safety is determined by proportion of subjects with primary adverse events within about 7 days of the ablation procedure.
• the catheter system is configured to reduce, for a predetermined patient population, incidence of serious adverse events during and after the ablation procedure of the catheter system up to 3 months following procedure.
• the catheter system is configured to clinically improve acute procedural success as defined by the proportion of subjects with electrical isolation of PVs at the end of the procedure.
• the catheter system is configured to clinically improve acute procedural success as defined by the proportion of subjects with electrical isolation of PVs using only an ablation mode.
• the ablation mode is about 90W at a flow rate of 8 milliliters/minute.
• the ablation mode is at least greater than about 50W at a flow rate of 8 milliliters/minute.
• the ablation mode is about 90W for at least about a 4 s duration of time with an RF generator.
• the catheter system is configured to clinically improve effectiveness as defined by the proportion of subjects with electrical isolation of PVs at all power settings combined the proportion of subjects with electrical isolation of PVs after first pass isolation.
• the catheter system is configured to clinically improve effectiveness as defined by the proportion of subjects with electrical isolation of PVs at all power settings combined the proportion of subjects with electrical isolation of PVs after a waiting period.
• the catheter system is configured to clinically improve effectiveness as defined by the proportion of subjects with electrical isolation of PVs at all power settings combined the proportion of subjects with electrical isolation of PVs after adenosine challenge.
• the catheter system is configured to clinically improve effectiveness as defined by the proportion of subjects and proportion of PVs with touch-up to remove ablation of acute reconnection among all targeted veins and touch-up location.
• the catheter system is configured to clinically improve effectiveness as defined by the proportion of subjects the anatomical location of acute PV reconnection after first encirclement.
• the catheter system is configured to clinically improve incidence of unanticipated adverse device effects during and following the ablation procedure used with the catheter system.
• the catheter system is configured to clinically improve incidence of serious adverse events and incidence of bleeding complication between 7 - 30 days after the ablation procedure performed by the catheter system.
• the catheter system is configured to clinically improve incidence of serious adverse events and incidence of bleeding complication at least 30 days after the ablation procedure performed by the catheter system.
• the incidence of bleeding complication is defined as major bleeding.
• incidence of bleeding complication is defined as clinically relevant non-major.
• incidence of bleeding complication is defined as minor bleeding.
• the catheter system is configured to clinically improve, for a predetermined patient population, a coagulum rate associated with RF ablation of the catheter system.
• the catheter system is configured to clinically improve, for a predetermined patient population, a steam pop rate compared with a prior clinically approved ablation catheter.
• the prior clinically approved ablation catheter is configured to perform RF ablation at approximately 50W or less with a flow rate of flow rate of 8 milliliters/minute and the catheter system is configured to perform RF ablation at approximately 90W with a flow rate of 8 milliliters/minute.
• the catheter system is configured to clinically improve lesion dimensions, for a predetermined patient population, including max depth, max diameter and surface diameter, as compared a prior clinically approved ablation catheter.
• the catheter system is configured to clinically improve average power used during ablation, for a predetermined patient population, as compared a prior clinically approved ablation catheter.
• the catheter system is configured to clinically improve maximum electrode temperature used during ablation, for a predetermined patient population, as compared a prior clinically approved ablation catheter.
• the catheter system is configured to clinically improve impedance drop during ablation, for a predetermined patient population, as compared a prior clinically approved ablation catheter.
• the catheter system is configured to clinically improve RF energy delivery at a target site.
• the catheter system is configured to clinically improve acute isolation of the pulmonary vein.
• the catheter system is configured to clinically improve pace from ring electrodes and microelectrodes during idle-state and during RF ablation.
• the catheter system is configured to clinically improve temperature feedback during ablation as compared a prior clinically approved ablation catheter.
• the chamber is adapted to receive fluid and the chamber has a plurality of irrigation apertures configured to allow fluid to flow from inside the chamber to outside the chamber.
• the distal end of the micro-element includes an exposed portion outside of the wall of the shell.
• the micro-element includes a micro-electrode element at its distal end and the at least one wire is attached to the micro-electrode element.
• the micro-element is configured for temperature sensing.
• the system includes a plurality of micro-elements each having a distal end, wherein the distal ends of the micro-elements are arranged in a radial pattern in the distal portion of the electrode about a longitudinal axis of the electrode.
• the plurality ranges between about two and six.
• the plurality is six.
• the system includes a first plurality of first micro-elements configured for impedance sensing and a second plurality of second micro-elements configured for temperature sensing.
• distal ends of the first micro-elements are arranged in a radial pattern along a circumference of the distal portion of the shell about a longitudinal axis of the electrode.
• distal ends of the second micro-elements are also arranged in a radial pattern along the circumference, interspersed between the first micro-elements.
• the distal ends of the second micro-elements are arranged in a radial pattern along a different circumference of the distal portion of the shell about the longitudinal axis of the electrode.
• the exposed portion extends at an angle having a distal component and a radial component relative to the longitudinal axis of the electrode.
• the exposed portion has an atraumatic configuration adapted to form a micro-depression in tissue without breaching the tissue.
• the system is configured to implement a method comprising selectively positioning a diagnostic catheter at a treatment site in the vasculature; selectively positioning the ablation catheter system according to any previous claim at the treatment site; performing PVI by ablating tissue at the treatment site with the ablation catheter system; and clinically improving, by the ablation catheter system, total fluid delivered by the ablation catheter system and via intravenous line during the ablation procedure.
• the system is configured to implement a method comprising inserting the ablation catheter system according to any preceding claim to a treatment site comprising cardiac tissue, the system comprising at least one electrode and at least one sensor into the body in proximity; ablating the cardiac tissue with the ablation catheter system; and achieving complete pulmonary vein isolation, by the ablation catheter system, for all patients of a predetermined patient population suffering from PAF.
• the system is configured to implement a method comprising inserting an ablation catheter system according to any preceding claim into a body of a living subject; urging the ablation catheter system into contact with a cardiac tissue in the body; generating ablative energy at a power output level at a level of current; transmitting the generated energy into the tissue via the ablation catheter system; ablating the cardiac tissue with the ablation catheter system; and clinically improving, by the ablation catheter system, safety and effectiveness resulting in approximately at least 80% less RF ablation time compared to ablation time of a previous clinically approved catheter system for treating PAF.
• the system is configured to implement a method comprising selectively positioning a diagnostic catheter at a treatment site in the vasculature; selectively positioning the ablation catheter system according to any previous claim at the treatment site; performing PVI by ablating tissue at the treatment site with the ablation catheter system; and clinically improving, by the ablation catheter system, safety and effectiveness for PAF with a contact force between the ablation catheter system and a target site working ranging between approximately 5 - 30 grams.
• the system is configured to implement a method comprising inserting the ablation catheter system according to any preceding claim to a treatment site comprising cardiac tissue, the system comprising at least one electrode and at least one sensor into the body in proximity; ablating the cardiac tissue with the ablation catheter system; achieving clinically improved safety and effectiveness for PAF with substantially shorter total procedure, ablation, fluoroscopy, and radiofrequency application times.
• the system is configured to implement a method comprising inserting an ablation catheter system according to any preceding claim into a body of a living subject; urging the ablation catheter system into contact with a cardiac tissue in the body; generating ablative energy at a power output level at a level of current; transmitting the generated energy into the tissue via the ablation catheter system; ablating the cardiac tissue with the ablation catheter system; and achieving, by the ablation catheter system, zero incidence of steam pop occurrence in both left and right atrial ablations using the ablation catheter system at a predetermined irrigation fluid rate and power setting that includes 90W.
• a method for performing clinically improved cardiac ablation including selectively positioning a diagnostic catheter at a treatment site in the vasculature; selectively positioning an ablation catheter system according to any previous claim at the treatment site; performing PVI by ablating tissue at the treatment site with the ablation catheter system; and clinically improving, by the ablation catheter system, total fluid delivered by the ablation catheter system and via intravenous line during the ablation procedure.
• a method for performing RF ablation on cardiac tissue during a pulmonary vein isolation procedure, the method including inserting an ablation catheter system according to any preceding claim to a treatment site comprising cardiac tissue, the system comprising at least one electrode and at least one sensor into the body in proximity; ablating the cardiac tissue with the ablation catheter system; and achieving complete pulmonary vein isolation, by the ablation catheter system, for all patients of a predetermined patient population suffering from PAF.
• a method for performing RF ablation on cardiac tissue during a pulmonary vein isolation procedure, the method including inserting an ablation catheter system according to any preceding claim into a body of a living subject; urging the ablation catheter system into contact with a cardiac tissue in the body; generating ablative energy at a power output level at a level of current; transmitting the generated energy into the tissue via the ablation catheter system; ablating the cardiac tissue with the ablation catheter system; and clinically improving, by the ablation catheter system, safety and effectiveness resulting in approximately at least 80% less RF ablation time compared to ablation time of a previous clinically approved catheter system for treating PAF.
• a method for performing clinically improved cardiac ablation including selectively positioning a diagnostic catheter at a treatment site in the vasculature; selectively positioning an ablation catheter system according to any previous claim at the treatment site; performing PVI by ablating tissue at the treatment site with the ablation catheter system; and clinically improving, by the ablation catheter system, safety and effectiveness for PAF with a contact force between the ablation catheter system and a target site working ranging between approximately 5 - 30 grams.
• a method for performing RF ablation on cardiac tissue during a pulmonary vein isolation procedure, the method including inserting an ablation catheter system according to any preceding claim to a treatment site comprising cardiac tissue, the system comprising at least one electrode and at least one sensor into the body in proximity; ablating the cardiac tissue with the ablation catheter system; and achieving clinically improved safety and effectiveness for PAF with substantially shorter total procedure, ablation, fluoroscopy, and radiofrequency application times.
• a method for performing RF ablation on cardiac tissue during a pulmonary vein isolation procedure, the method including inserting an ablation catheter system according to any preceding claim into a body of a living subject; urging the ablation catheter system into contact with a cardiac tissue in the body; generating ablative energy at a power output level at a level of current; transmitting the generated energy into the tissue via the ablation catheter system; ablating the cardiac tissue with the ablation catheter system; and achieving, by the ablation catheter system, zero incidence of steam pop occurrence in both left and right atrial ablations using the ablation catheter system at a predetermined irrigation fluid rate and power setting that includes 90W.
• the step of achieving further comprises applying an average force of approximately 7.5 grams by the ablation catheter system to the cardiac tissue during use.
• the step of achieving further comprises applying an average force of approximately 9.1 grams by the ablation catheter system to the cardiac tissue during use.
• the step of achieving further comprises applying an average force of approximately 17.7 grams by the ablation catheter system to the cardiac tissue during use.
• the step of achieving further comprises applying an average force of approximately 13.6 grams by the ablation catheter system to the cardiac tissue during use.
• a diseased heart is the treatment site of the method.
• the method includes clinically improving effective electrogram signal attenuation and clinically equivalent to or better lesions in all four cardiac chambers as compared to a prior clinically approved ablation catheter system.
• the method includes clinically reducing the total fluid delivered by the ablation catheter system to the treatment site during cardiac ablation by approximately 76.5% from a prior clinically approved ablation catheter system.
• the method includes delivering, by the ablation catheter system, no more than approximately 382 mL or less of treatment fluids to the treatment site during the ablation procedure.
• the method includes clinically reducing the total ablation procedure time by the ablation catheter system by approximately 50% from a prior clinically approved ablation catheter system.
• the method includes clinically, by the ablation catheter system, the total ablation procedure time to no more than approximately 105.2 minutes or less.
• the method includes clinically reducing the total ablation time by the ablation catheter system by approximately 62% from a prior clinically approved ablation catheter system.
• the method includes clinically, by the ablation catheter system, the total ablation time to no more than approximately 46 minutes or less.
• the method includes clinically reducing the total fluoroscopy time of the ablation catheter system by approximately 80% from a prior clinically approved ablation catheter system.
• the method includes clinically, by the ablation catheter system, the total fluoroscopy time to no more than approximately 6.6 minutes or less.
• the method includes clinically reducing the total RF application duration time of the ablation catheter system by approximately 83% from a prior clinically approved ablation catheter system.
• the method includes clinically reducing, by the ablation catheter system, total RF application duration time to no more than approximately 8.1 minutes or less.
• total procedure and fluoroscopy times for the ablation catheter system includes approximately 105 minutes and 6.6 minutes respectively.
• the method includes placing an esophageal temperature monitoring device; and monitoring esophageal temperature using the temperature monitoring device.
• the method includes confirming ACT in greater than or equal to 350 seconds before insertion of the ablation catheter system into the left atrium and maintain throughout the procedure.
• the method includes generating a left atrial anatomical map prior to an ablation procedure in the LA.
• the method includes using a pre-ablation flow rate delay of minimal 2 seconds before RF application.
• the method includes RF ablating via RF power application of up to 90W for up to 4 seconds.
• the method includes moving the ablation catheter system from a first location of the treatment site to a second location of the treatment site.
• the step of moving the ablation catheter system includes moving the ablation catheter system approximately 4 millimeter if clinically effective ablation is achieved.
• the step of moving the ablation catheter system includes moving the ablation catheter system approximately if clinically effective ablation is achieved within 20 seconds as determined by electrogram reduction and/or impedance drop.
• the method includes performing, with the ablation catheter system, ablation of the left atrium and real time PV isolation.
• the method includes confirming entrance block in all targeted PVs by the diagnostic catheter.
• the method includes visualizing the treatment site and the ablation catheter system using fluoroscopy.
• the method includes minimizing risk of esophageal injury by using an esophageal temperature probe, wherein temperature rise is detected in the esophagus, then permitting tissue of the treatment site to cool to a predetermined temperature; and visualizing the esophagus under fluoroscopy.
• duration of ablation did not exceed 30 seconds on a posterior wall at the treatment site.
• the method includes clinically reducing PVI ablation time of the ablation catheter system, as compared to a prior clinically approved ablation catheter system, between first RF application and last RF application on a PV before isolation confirmed and circumferential ablation achieved.
• the method includes clinically reducing subject PVI ablation time of the ablation catheter system, as compared to a prior clinically approved ablation catheter system, between first RF application and last RF application before all PVI complete.
• the method includes clinically reducing total ablation time of the ablation catheter system, as compared to a prior clinically approved ablation catheter system, between first RF application and last RF application before all PVI complete.
• total ablation time is determined by total procedure time from first femoral puncture to last catheter removal.
• the method includes clinically improving ablation parameters of the ablation catheter system during an ablation procedure, as compared to a prior clinically approved ablation catheter system, including temperature, impedance, power, contact force, and RF duration.
• the method includes clinically improving atrial mapping time.
• the method includes clinically improving LA catheter dwell time from ablation catheter LA insertion to ablation catheter removal from the LA.
• the method includes irrigating the cardiac tissue via the ablation catheter system.
• the method includes minimizing acute or minimal subendocardial hemorrhages in the chambers and mitral valves by using the ablation catheter system in eliminating or ameliorating persistent atrial fibrillation.
• the method includes demonstrating clinically improved safety and/or effectiveness of the ablation catheter system for patients of a predetermined patient population, the predetermined patient population being divided in three different arrhythmia subgroups: Ventricular Tachycardia, complex Atrial Tachycardia or re-do Paroxysmal Atrial Fibrillation, and Persistent Atrial Fibrillation.
• the method includes clinically improving safety and effectiveness of the ablation catheter system to at least one of the left atrium, right atrium, left ventricle, and right ventricle.
• an ablation catheter system including selectively positioning a diagnostic catheter at a treatment site in the vasculature; selectively positioning the ablation catheter system according to any previous claim at the treatment site; performing PVI by ablating tissue at the treatment site with the ablation catheter system; and clinically improving, by the ablation catheter system, total fluid delivered by the ablation catheter system and via intravenous line during the ablation procedure.
• an ablation catheter system including inserting the ablation catheter system according to any preceding claim to a treatment site comprising cardiac tissue, the system comprising at least one electrode and at least one sensor into the body in proximity; ablating the cardiac tissue with the ablation catheter system; and achieving complete pulmonary vein isolation, by the ablation catheter system, for all patients of a predetermined patient population suffering from PAF.
• an ablation catheter system including inserting the ablation catheter system according to any preceding claim into a body of a living subject; urging the ablation catheter system into contact with a cardiac tissue in the body; generating ablative energy at a power output level at a level of current; transmitting the generated energy into the tissue via the ablation catheter system; ablating the cardiac tissue with the ablation catheter system; and clinically improving, by the ablation catheter system, safety and effectiveness resulting in approximately at least 80% less RF ablation time compared to ablation time of a previous clinically approved catheter system for treating PAF.
• an ablation catheter system including selectively positioning a diagnostic catheter at a treatment site in the vasculature; selectively positioning the ablation catheter system according to any previous claim at the treatment site; performing PVI by ablating tissue at the treatment site with the ablation catheter system; and clinically improving, by the ablation catheter system, safety and effectiveness for PAF with a contact force between the ablation catheter system and a target site working ranging between approximately 5 - 30 grams.
• an ablation catheter system including inserting the ablation catheter system according to any preceding claim to a treatment site comprising cardiac tissue, the system comprising at least one electrode and at least one sensor into the body in proximity; ablating the cardiac tissue with the ablation catheter system; and achieving clinically improved safety and effectiveness for PAF with substantially shorter total procedure, ablation, fluoroscopy, and radiofrequency application times.
• an ablation catheter system including inserting the ablation catheter system according to any preceding claim into a body of a living subject; urging the ablation catheter system into contact with a cardiac tissue in the body; generating ablative energy at a power output level at a level of current; transmitting the generated energy into the tissue via the ablation catheter system; ablating the cardiac tissue with the ablation catheter system; and achieving, by the ablation catheter system, zero incidence of steam pop occurrence in both left and right atrial ablations using the ablation catheter system at a predetermined irrigation fluid rate and power setting that includes 90W.
• the step of achieving comprises applying an average force of approximately 7.5 grams by the ablation catheter system to the cardiac tissue during use.
• the step of achieving further comprises applying an average force of approximately 9.1 grams by the ablation catheter system to the cardiac tissue during use.
• the step of achieving further comprises applying an average force of approximately 17.7 grams by the ablation catheter system to the cardiac tissue during use.
• the step of achieving further comprises applying an average force of approximately 13.6 grams by the ablation catheter system to the cardiac tissue during use.
• a diseased heart is the treatment site of the method.
• the use includes clinically improving effective electrogram signal attenuation and clinically equivalent to or better lesions in all four cardiac chambers as compared to a prior clinically approved ablation catheter system.
• the use includes clinically reducing the total fluid delivered by the ablation catheter system to the treatment site during cardiac ablation by approximately 76.5% from a prior clinically approved ablation catheter system.
• the use includes delivering, by the ablation catheter system, no more than approximately 382 mL or less of treatment fluids to the treatment site during the ablation procedure.
• the use includes clinically reducing the total ablation procedure time by the ablation catheter system by approximately 50% from a prior clinically approved ablation catheter system.
• the use includes clinically, by the ablation catheter system, the total ablation procedure time to no more than approximately 105.2 minutes or less.
• the use includes clinically reducing the total ablation time by the ablation catheter system by approximately 62% from a prior clinically approved ablation catheter system.
• the use includes clinically, by the ablation catheter system, the total ablation time to no more than approximately 46 minutes or less.
• the use includes clinically reducing the total fluoroscopy time of the ablation catheter system by approximately 80% from a prior clinically approved ablation catheter system.
• the use includes clinically, by the ablation catheter system, the total fluoroscopy time to no more than approximately 6.6 minutes or less.
• the use includes clinically reducing the total RF application duration time of the ablation catheter system by approximately 83% from a prior clinically approved ablation catheter system.
• the use includes clinically reducing, by the ablation catheter system, total RF application duration time to no more than approximately 8.1 minutes or less.
• total procedure and fluoroscopy times for the ablation catheter system included approximately 105 minutes and 6.6 minutes respectively.
• the use includes placing an esophageal temperature monitoring device; and monitoring esophageal temperature using the temperature monitoring device.
• the use includes confirming ACT in greater than or equal to 350 seconds before insertion of the ablation catheter system into the left atrium and maintain throughout the procedure.
• the use includes generating a left atrial anatomical map prior to an ablation procedure in the LA.
• the use includes using a pre-ablation flow rate delay of minimal 2 seconds before RF application.
• the use includes RF ablating via RF power application of up to 90W for up to 4 seconds.
• the use includes moving the ablation catheter system from a first location of the treatment site to a second location of the treatment site.
• the step of moving the ablation catheter system includes moving the ablation catheter system approximately 4 millimeter if clinically effective ablation is achieved.
• the step of moving the ablation catheter system includes moving the ablation catheter system approximately if clinically effective ablation is achieved within 20 seconds as determined by electrogram reduction and/or impedance drop.
• the use includes performing, with the ablation catheter system, ablation of the left atrium and real time PV isolation.
• the use includes confirming entrance block in all targeted PVs by the diagnostic catheter.
• the use includes visualizing the treatment site and the ablation catheter system using fluoroscopy.
• the use includes minimizing risk of esophageal injury by using an esophageal temperature probe, wherein temperature rise is detected in the esophagus, then permitting tissue of the treatment site to cool to a predetermined temperature; and visualizing the esophagus under fluoroscopy.
• the use includes a duration of ablation did not exceed 30 seconds on a posterior wall at the treatment site.
• the use includes clinically reducing PVI ablation time of the ablation catheter system, as compared to a prior clinically approved ablation catheter system, between first RF application and last RF application on a PV before isolation confirmed and circumferential ablation achieved.
• the use includes clinically reducing subject PVI ablation time of the ablation catheter system, as compared to a prior clinically approved ablation catheter system, between first RF application and last RF application before all PVI complete.
• the use includes clinically reducing total ablation time of the ablation catheter system, as compared to a prior clinically approved ablation catheter system, between first RF application and last RF application before all PVI complete.
• the use includes total ablation time is determined by total procedure time from first femoral puncture to last catheter removal.
• the use includes clinically improving ablation parameters of the ablation catheter system during an ablation procedure, as compared to a prior clinically approved ablation catheter system, including temperature, impedance, power, contact force, and RF duration.
• the use includes clinically improving atrial mapping time.
• the use includes clinically improving LA catheter dwell time from ablation catheter LA insertion to ablation catheter removal from the LA.
• the use includes irrigating the cardiac tissue via the ablation catheter system.
• the use includes minimizing acute or minimal subendocardial hemorrhages in the chambers and mitral valves by using the ablation catheter system in eliminating or ameliorating persistent atrial fibrillation.
• the use includes demonstrating clinically improved safety and/or effectiveness of the ablation catheter system for patients of a predetermined patient population, the predetermined patient population being divided in three different arrhythmia subgroups: Ventricular Tachycardia, complex Atrial Tachycardia or re-do Paroxysmal Atrial Fibrillation, and Persistent Atrial Fibrillation.
• the use includes clinically improving safety and effectiveness of the ablation catheter system to at least one of the left atrium, right atrium, left ventricle, and right ventricle.
• a system for drug refractory symptomatic paroxysmal atrial fibrillation (PAF).
• the system includes an elongated body; an electrode assembly coupled to the elongated body and comprising a shell configured with an inner chamber and a wall defining a proximal portion and a distal portion, the wall of the distal portion having at least one aperture; a micro-element extending through the inner chamber between the proximal portion and the distal portion, the micro-element having a distal end received in the at least one aperture, the distal end being at least coextensive with an outer surface of the wall.
• the system is configured with an ablation mode including a power setting of approximately 90W applied to tissue for approximately four (4) second increments with a break period of approximately 4 seconds between applications.
• the ablation mode is configured to cause a maximum tissue temperature of approximately 76 °C.
• the system includes an irrigation pump configured to deliver an infusion of treatment solution by and through the elongated body.
• the irrigation pump is configured to deliver approximately 2 milliliters/minute of treatment solution when RF energy is not being delivered during RF ablation.
• the irrigation pump is configured to deliver approximately 8 milliliters/minute of treatment solution when RF energy is not being delivered during RF ablation.
• a force sensory system is included for detecting contact force applied by the catheter system to the treatment site during use, the contact force between the system and a target site ranging between approximately 5 - 30 grams.
• the system is configured to achieve zero incidence of steam pop occurrence in both left and right atrial ablations using the ablation mode.
• the ablation mode is configured to cause an increase of a maximum tissue temperature by at least about 13% between first and second ablation applications.
• the ablation mode is configured to cause an approximately 40% deeper lesion between first and second ablation applications, wherein the ablation mode further includes a contact force between the ablation catheter system and a target site ranging between approximately 10 - 30g.
• the ablation mode is configured to cause an approximately 40% deeper lesion between first and second ablation applications and avoids formation of char, coagulum, steam pop.
• the ablation mode includes a point-by-point "kissing" ablation approach causing a continuous and transmural linear lesion line at the atrial wall with minimal over-lapped lesions.
• the ablation mode includes a temperature control and irrigation link.
• the electrode assembly includes one or more ring electrodes and microelectrodes the catheter system being configured to clinically improve pace from one or more ring electrodes and microelectrodes during idle-state and during RF ablation.
• the system is configured to achieve approximately at least 80% less RF ablation time compared to ablation time of a previous clinically approved catheter system for treating PAF.
• the distal end of the micro-element comprising an exposed portion outside of the wall of the shell, the micro-element configured for temperature sensing.
• the micro-element further comprising a first plurality of first micro-elements configured for impedance sensing and a second plurality of second micro-elements configured for temperature sensing.
• the distal ends of the first micro-elements can be arranged in a radial pattern along a circumference of the distal portion of the shell about a longitudinal axis of the electrode assembly.
• a system including an elongated body; an electrode assembly coupled to the elongated body configured with an inner chamber and a wall defining a proximal portion and a distal portion, the wall comprising at least one aperture; and a micro-element extending through the inner chamber between the proximal portion and the distal portion.
• the system is configured with an ablation mode comprising a power setting of approximately 90W applied to tissue for approximately four (4) second increments to achieve approximately zero incidence of steam pop occurrence in both left and right atrial ablations and complete pulmonary vein isolation.
• the ablation mode is configured with a point-by-point "kissing" ablation approach causing a continuous and transmural linear lesion line at the atrial wall with minimal over-lapped lesions.
• the ablation mode is configured to cause a maximum tissue temperature of approximately 76 °C.
• a method or use including selectively positioning an ablation catheter system at a treatment site; ablating tissue at the treatment site with the ablation catheter system using a power setting of approximately 90W applied to tissue for approximately four (4) second increments with a break period of approximately 4 seconds between applications;
• the method or use includes achieving, by the ablation catheter system, a maximum tissue temperature of approximately 76 °C to the treatment site during the ablation procedure.
• the step of ablating tissue includes increasing of a maximum tissue temperature by at least about 13% between first and second ablation applications.
• the step of ablating tissue includes a point-by-point "kissing" ablation approach causing a continuous and transmural linear lesion line at the atrial wall with minimal over-lapped lesions.
• the step of ablating tissue includes achieving a lesion depth approximately 40% deeper between first and second ablation applications, the method or use further comprising applying to the treatment site, by a distal end of the ablation catheter system, a contact force ranging between approximately 5 - 30 grams.
• the ablation catheter system includes an elongated body; an electrode assembly comprising a shell configured with an inner chamber and a wall; and a micro-element extending through the inner chamber between the proximal portion and the distal portion, the micro-element having a distal end received in the at least one aperture, the distal end being at least coextensive with an outer surface of the wall.
• the predetermined patient population size is at least about 50 patients.
• the method or use includes delivering, by and through the elongated body, a continuous infusion of approximately 8 milliliters/minute of treatment solution when not delivering RF energy during RF ablation.
• the method or use includes moving the ablation catheter system approximately 4 millimeter if clinically effective ablation is achieved within 20 seconds as determined by electrogram reduction and/or impedance drop.
• a method or use including delivering an ablation catheter system to a treatment site comprising cardiac tissue, the system comprising at least one electrode and at least one sensor in proximity with the other; ablating cardiac tissue with the ablation catheter system at a predetermined irrigation fluid rate and power setting comprising approximately 90W; and achieving approximately zero incidence of steam pop occurrence in both left and right atrial ablations and complete pulmonary vein isolation, by the ablation catheter system, for all patients of a predetermined patient population suffering from PAF.
• the ablation catheter system includes an elongated body; an electrode assembly comprising a shell configured with an inner chamber and a wall; and a micro-element extending through the inner chamber between the proximal portion and the distal portion, the micro-element having a distal end received in the at least one aperture, the distal end being at least coextensive with an outer surface of the wall.
• the step of achieving complete pulmonary vein isolation further comprises applying an average force of approximately 7.5 grams by the ablation catheter system to the cardiac tissue during use and achieving a target temperature of approximately 50°C and ablation duration of approximately 4 seconds.
• the step of achieving complete pulmonary vein isolation further comprises applying an average force of approximately 9 grams by the ablation catheter system to the cardiac tissue during use and achieving a target temperature of approximately 55°C and ablation duration of approximately 4 seconds.
• the step of achieving complete pulmonary vein isolation further comprises applying an average force of approximately 17.7 grams by the ablation catheter system to the cardiac tissue during use and achieving a target temperature of approximately 1360°C and ablation duration of approximately 4 seconds.
• the step of achieving complete pulmonary vein isolation further comprises applying an average force of approximately 13.6 grams by the ablation catheter system to the cardiac tissue during use and achieving a target temperature of approximately 1360°C and ablation duration of approximately 2 seconds.
• the method or use includes delivering, by the ablation catheter system, the predetermined irrigation flow rate of approximately 380 mL or less of treatment fluids to the treatment site during the ablation procedure.
• the step of achieving complete pulmonary vein isolation includes a total ablation procedure time less than or equal to approximately 105 minutes.
• the step of achieving complete pulmonary vein isolation includes a total ablation procedure time less than or equal to approximately 46 minutes.
• the step of achieving complete pulmonary vein isolation includes a total fluoroscopy time of less than or equal to approximately 6.5 minutes or less.
• the step of achieving complete pulmonary vein isolation includes a total RF application duration time of approximately 8 minutes or less.
• the step of achieving complete pulmonary vein isolation includes a total RF application duration time of 30 seconds on a posterior wall of the treatment site.
• the step of ablating the cardiac tissue includes a point-by-point "kissing" ablation approach causing a continuous and transmural linear lesion line at the atrial wall with minimal over-lapped lesions.
• the terms “about” or “approximately” for any numerical values or ranges indicate a suitable dimensional tolerance that allows the part or collection of components to function for its intended purpose as described herein. More specifically, “about” or “approximately” can refer to the range of values ⁇ 10% of the recited value, e.g. “about 90%” can refer to the range of values from 81% to 99%.
• the terms “patient,” “host,” “user,” and “subject” refer to any human or animal subject and are not intended to limit the systems or methods to human use, although use of the subject invention in a human patient represents a preferred embodiment.
• vasculature of a "subject” or “patient” can be vasculature of a human or any animal.
• an animal can be a variety of any applicable type, including, but not limited thereto, mammal, veterinarian animal, livestock animal or pet type animal, etc.
• the animal can be a laboratory animal specifically selected to have certain characteristics similar to a human (e.g., rat, dog, pig, monkey, or the like).
• the subject can be any applicable human patient, for example.
• doctor can include a doctor, surgeon, or any other individual or delivery instrumentation associated with delivery of a RF ablation catheter for the treatment of atrial fibrillation to a subject.
• safety refers to a relatively low severity of adverse events, including adverse bleeding events, infusion or hypersensitivity reactions.
• Adverse bleeding events can be the primary safety endpoint and include, for example, major bleeding, minor bleeding, and the individual components of the composite endpoint of any bleeding event.
• the term “clinically effective” can mean that it has been proven by a clinical trial wherein the clinical trial has met the approval standards of U.S. Food and Drug Administration, EMEA or a corresponding national regulatory agency.
• a clinical study can be an adequately sized, randomized, double-blinded controlled study used to clinically prove the effects of the cardiac ablation device(s) and related system(s) of this disclosure. Most preferably to clinically prove the effects of the device(s) with respect to all targeted pulmonary veins, for example, to achieve a clinically effective outcome in for the patient and/or achieve pulmonary vein isolation in those afflicted veins.
• the solution of this disclosure is not a method for treatment of the human or animal body by surgery or therapy and is not a diagnostic method practiced on the human or animal body.
• the clinical attribute may not be related to a method for treatment of the human or animal body by surgery or therapy or a diagnostic method practiced on the human or animal body.
• CT computed tomography
• PET positron emission tomography
• SPECT single-photon emission computed tomography
• Fig. 1 is a schematic illustration of a conventional system 20 for cardiac catheterization as known in the art.
• System 20 may comprise an invasive probe in the form of a catheter 28 and a control console 34.
• the signal processor 36 of the console 34 processes signals from sensors of the catheter 28 in order to determine the position coordinates of the distal section 13, typically including both location and orientation coordinates.
• Catheter 28 and corresponding features of the study of this disclosure can be understood as including features more clearly described in Appendix 1 which includes U.S. Pat. Nos.
• test ablation 90W, 4s
• the test ablation mode referred to in the study of this disclosure was understood as 90W at a flow rate of 8 milliliters/minute and is sometimes referred herein as QMODE+.
• QMODE+ The ability of the novel test ablation mode to modulate power based on temperature reduces the potential for electrode and tissue overheating, which could, in turn, help avoid char formation and steam pops.
• the safety profile observed with catheter 28 and corresponding test ablation mode was promising, with a low incidence of PAEs and no unexpected adverse device effects.
• microelectrodes have been useful to avoid radiofrequency delivery on scar tissue.
• the safety of test ablation will be further evaluated in larger clinical studies.
• One of the limitations of point-by-point catheter ablation is the longer procedure time associated with individual lesion creation; this prompted adoption of balloon-based catheters for PVI. Nonetheless, current balloon technologies are mostly limited to PV ablation.
• the current study demonstrated reduction of procedural time with test ablation, with shorter procedural times than typically observed with current commercially-available CF and non-CF catheters.
• the catheter 28 can include an elongated catheter body 11, a deflectable intermediate section 12, a distal section 13 carrying at least a tip electrode 15 on its distal tip end 30, and a control handle 16.
• the catheter 28 can be one that is a steerable multi-electrode luminal catheter with a deflectable tip designed to facilitate electrophysiological mapping of the heart and to transmit radiofrequency (RF) current to the catheter tip electrode for ablation purposes.
• An operator 26, such as a cardiologist can insert catheter 28 through the vascular system of a patient 24 so that a distal section 13 of the catheter enters a chamber of the patient's heart 22.
• the operator advances the catheter so that a distal tip 30 of the catheter engages endocardial tissue 70 at a desired location or locations.
• Catheter 28 is connected by a suitable connector at its proximal end to console 34.
• the console may include a RF generator, which supplies high-frequency electrical energy via the catheter for ablating tissue in the heart at the locations engaged by the distal section 13.
• the catheter 28 can be used in conjunction with a dispersive pad (e.g., indifferent electrode).
• the catheter 28 can include a shaft that measures 7.5 F with 8 F ring electrodes.
• the catheter 28 can also have a force-sensing system that provides a real-time measurement of contact force between the catheter tip and the heart wall.
• a force-sensing system that provides a real-time measurement of contact force between the catheter tip and the heart wall.
• a range of power e.g., 50-100W
• durations 3-15 seconds
• using higher power to promote resistive heating while shortening the duration to limit the impact of conductive heating through adjacent tissue provides the optimal balance for efficiency, effectiveness and safety.
• the conclusion from these studies has been implemented as the test ablation mode using ablation parameters of 90W for a duration of 4s (irrigation setting at 8 milliliters/minute).
• distal tip section 13 can include an electrode assembly 19 and at least one micro-element 20 having an atraumatic distal end adapted for direct contact with target tissue 22.
• Catheter body 12 can have a longitudinal axis, and an intermediate section 14 distal of the catheter body 12 that can be uni- or bi-directionally deflectable off-axis from the catheter body 12.
• the electrode assembly 19 carrying at least one micro-element.
• Proximal of the catheter body is control handle 16 that allows an operator to maneuver the catheter, including deflection of the intermediate section 14.
• the shaft can be a relatively high torqueable with the distal tip section 13 being relatively deflectable containing electrode assembly 19 with an array of electrodes which includes a 3.5 mm tip dome with three microelectrodes. All of the electrodes may be used for recording and stimulation purposes. A rocker lever can be used to deflect the tip.
• the high-torque shaft also allows the plane of the curved tip to be rotated to facilitate accurate positioning of the catheter tip at the desired site. Three curve types configurations designated "D,” "F,” and “J" are available.
• the electrode assembly 19 serves to deliver RF energy from the RF generator to the desired ablation site.
• the electrode assembly 19 and ring electrodes can be made from noble metals.
• the catheter 28 can also include six thermocouple temperature sensors that are embedded in the 3.5 mm tip electrode.
• the RF generator software can be configured for cardiac ablation applications by generating RF energy for delivery to a site in the heart via catheter 28.
• the RF generator can include functions for controlling ablation parameters at the ablation electrodes of the catheter. Ablation parameters, such as power, impedance, ablation duration, and temperature are recorded and can be exported at the end of the procedure to a USB device.
• the RF generator can include a console that contains the hardware that provides the delivery of RF energy.
• a local monitor can be included with a user interface. The monitor can include control instructions for the generator and instruct the console what function to perform. It can also communicate with a workstation.
• a foot pedal can be included for the user to start and stop ablation.
• a saline input port with a standard luer fitting can terminate from the open lumen.
• This saline port serves to permit the injection of normal saline to irrigate the electrode assembly 19.
• heparinized normal saline can be passed through the internal lumen of the catheter 28 and through the electrode assembly 19, to irrigate and cool the ablation site as well as the electrode tip.
• An irrigation pump can be used in certain examples to control the saline irrigation.
• FIG. 4A shows a cut-away sectional view of distal tip section 13 of the catheter 28 in accordance with an embodiment.
• An irrigation assembly 51 mates with segment 81 of the catheter 28 and with the one or more electrodes 47 of assembly 19.
• the assembly 51 comprises an axial lumen 83 that conducts irrigation fluid distally toward a blocking terminus 85 that prevents the irrigation fluid from continuing in a forward direction.
• the irrigation fluid flow is indicated by an arrow 87.
• a plurality of channels 89 branch trans-axially outward at 90° angles to the axial lumen 83, diverting the flow outward as indicated by arrows 91.
• the irrigation fluid enters the lumen 49 transverse to the axis of the catheter 28, generally toward the lateral channels in the electrode 47, such as the channels 61.
• irrigation flow through the channels 61 would be disfavored, because the flow would be required to reverse course, and to turn more than 90 degrees to enter the proximally angled channels, such as the channels 61. It is an advantage of the arrangement of FIG. 4 that the irrigation flow is relatively more evenly distributed to all the holes in the one or more electrodes 47 than if the flow exited the assembly 51 in a forward direction.
• An irrigation pump can be used to control the saline irrigation.
• the catheter 28 can interface with standard recording equipment and a compatible RF generator via accessory extension cables with the appropriate connectors.
• the catheter 28 can include a location sensor embedded in the distal tip section 13 that transmits location and contact force information to the navigation system.
• An appropriate reference device can be required for location reference position purposes.
• FIG. 4B is a schematic cross-section of the distal segment of the ablation catheter of FIG. 4A which as shown terminates at distal tip section 13, which is formed from a biocompatible conductor, such as platinum, palladium, gold, iridium, or an alloy of the aforementioned, and which has an axis of symmetry 70.
• the cross-section of the distal end illustrated in FIG. 4B is taken in a plane containing axis 70.
• An external surface of distal tip section 13 is divided into three regions: a cylindrical region 78 at the proximal end of the tip, a plane region 82 at the distal end of the tip, and a curved annular region 86 joining the cylindrical region to the plane region.
• distal tip section 13 is penetrated by irrigation channels, so that the outer surface is pierced by irrigation apertures that terminate the channels.
• Irrigation fluid may be directed into the irrigation channels via an internal manifold 94 formed in the distal tip.
• the irrigation fluid for the manifold is provided by a dedicated conduit (not shown in the figures) within the lumen.
• At least one cavity is formed in the cylindrical region 78. At least one cavity is formed in the curved annular region 86 of the external surface.
• the embodiment described herein comprises three cavities which are distributed symmetrically with respect to axis 70, and three cavities of the curved annular region 86 are also distributed symmetrically with respect to the axis. and each cavity is configured to accept and mate with a respective microelectrode 120 of the prior discussed tip electrode 15.
• Each cavity of the curved annular region 86 is configured to accept and mate with a respective microelectrode 140.
• Microelectrodes 120 are configured to be inserted into respective cavities in the cylindrical region 78.
• Microelectrodes 140 are configured to be inserted into respective cavities of the curved annular region 86.
• Fig. 5A shows a graph of the generator RF power delivery over time at 35W for the study of this disclosure whereby maximum duration is set to 30 seconds.
• Fig. 5B shows a graph of the generator RF power delivery over time at 50W for the study of this disclosure whereby maximum duration is set to 30 seconds.
• Fig. 6A shows a graph of the generator RF power delivery over time at 90W for the study of this disclosure whereby maximum duration is set to 4 seconds.
• Fig. 6B shows a graph of the generator RF power delivery over time at 90W for the study of this disclosure whereby maximum duration is set to 4 seconds.
• the approach depicted in Figs. 6A-B is to titrate power. At this setting, power delivery is delivered at a constant irrigation flow of 8 milliliters/minute with no modulation given the short duration.
• Fig. 7 is a graph showing biophysical parameters of an example ablation lesion caused by catheter 28 of this disclosure. This includes a 2 sec pre-cooling phase, followed by a 4 second ablation lesion. Note the power modulation that is particularly striking in the last 1.5 seconds of energy delivery to maintain the target temperature of 60°C.
• Fig. 8 a meta-analysis of results for estimated average safety composite endpoints for prior devices for PAF is presented. Data from recent clinical trials for devices similar to the catheter 28 in the current study were reviewed as a first step to deriving the performance goal for the safety endpoint. A meta-analysis approach was taken to estimate the average composite endpoint rate. Based on the plot, the upper bound of the 95% confidence interval was estimated to be equal to 9%. The proposed performance goal of 14% would reflect an approximately 50% increase in risk from the upper bound of the 95% CI.
• pericardial effusion during AF ablation is around 1.2% to 1.3%. Cardiac perforation may result from catheter manipulation or application of radiofrequency current. Published risks of cardiac perforation range from ⁇ 1%to 2.4%. However, the risk of perforation is decreased with advances in catheter technology. This potentially life-threatening injury may result in cardiac tamponade and may require percutaneous pericardial drainage or surgical repair. Significant hemodynamic compromise can result in neurologic injury or death. An increased risk of cardiac perforation may be associated with the use of a saline-irrigated electrode catheter due to its ability to create a larger, deeper RF lesion. This risk is greatest in a thin walled chamber (i.e., RA, LA, appendage, or RV).
• Pulmonary vein stenosis is a well-known complication of radiofrequency catheter ablation of atrial fibrillation. Incidence of severe PVS (>70% diameter reduction) was found to be ⁇ 1% in a recent study with 976 subjects. Incidence of only 0.5% was reported in a large systematic review on complications of radiofrequency catheter ablation.
• Atrial esophageal fistula AEF
• Esophageal injury by endoscopy has a prevalence between 2.2 to 21%.
• Esophageal perforation is a dreaded complication of atrial fibrillation ablation that occurs in 0.02 to 11% of atrial fibrillation ablation procedures. Delayed diagnosis is associated with the development of atrial-esophageal fistula (AEF) and increased mortality.
• Complication rates for esophageal injury are quite varied, depending upon lesion location and type of lesion found (erythema, necrotic ulceration, perforation, or fistula formation).
• the incidence of AEF post-ablation of AF is supposed to be around 0.1% of the procedures.
• Studies using luminal temperature monitoring to identify potentially dangerous heating of the esophagus during ablation have not been able to demonstrate reduction in incidence.
• Radiofrequency current may cause occlusion of a coronary artery, either by direct thermal damage, spasm, or thrombus formation.
• Acute coronary artery occlusion is a very rare but potentially life-threatening complication of RFCA.
• Coronary arterial occlusion could produce myocardial infarction (MI), angina or death.
• MI myocardial infarction
• Occlusion of a coronary artery can be treated by restoring coronary blood flow through pharmacological, catheter and/or surgical intervention as medically indicated.
• Thrombus generation during the procedure may also pose a serious and even life-threatening risk to the patient. Thrombus may form on the ablation electrode during the application of radiofrequency current with or without any change in impedance. The thrombus might become dislodged and embolize to produce an ischemic stroke, MI, or other occlusive injury. Although some observational studies have shown a relatively lower stroke rate after catheter ablation, whether catheter ablation can reduce the thromboembolic risk remains unclear.
• the mean incidence of thromboembolism associated with AF ablation was approximately between 1% and 2%. More recently, incidence of thromboembolism has been reported up to 5% of patients undergoing AF ablation despite perioperative anticoagulation. Ischemic stroke events typically occur within 24 hours of the AF ablation procedure with the higher risk period covering for the first two weeks following ablation.
• Pulmonary hemorrhage is a rare but severe complication of PVI. Late hemoptysis and pulmonary hypertension can occur secondary to pulmonary vein stenosis (PVS) after ablation. Acute pulmonary hemorrhage also has been reported. Mechanical trauma from catheter manipulation is a possible mechanism for pulmonary hemorrhage. Injury to a cardiac valve may result from catheter manipulation or the application of radiofrequency current (risk ⁇ 1%). This may produce valvular insufficiency and possibly require valve replacement surgery.
• Fig. 9A is an example temperature distribution display associated with the catheter 28 of the study in this disclosure.
• Fig. 9B is an example "bulls eye” display associated with values for each thermocouple reading of the catheter 28 of the study in this disclosure.
• the "bulls eye” display provides temperature information to the physician.
• An optional numerical value of the temperature from the RF Generator can be displayed on the "bulls eye” determined by the physician's preference to display or not to display).
• the graphic of the bull's eye provides relative tip to tissue interface temperature readings obtained from the 6 thermocouples. The graphic provides the physician with an indication as to which part of the catheter tip 13 has contact with the tissue 22.
• the graphic can also provide the physician with an indication of the tip-to-tissue stability. For example, if the catheter tip 13 slips, the temperatures obtained from the thermocouples will change which will be visually displayed on the "bulls eye" as well as on the graphic of the tip 13 of the catheter 28.
• the colors in the displays can change as the temperature of the thermocouples change.
• the colors of the graphic of Fig. 9B though depicted here in black and white, can range from dark blue (minimum temperature) to dark red (maximum temperature) and the circular presentation allows the physician to visualize the relative temperatures of distal and proximal thermocouples in the tip (viewed from the center outward).
• the outer halo provides the orientation of the catheter tip in 3-dimensional space.
• Fig. 10 is a temperature distribution monitoring the maximum temperature measured and used to verify the proper response of the temperature distribution of the catheter tip 13 during the RF ablation session.
• the temperature feedback display during ablation is shown in Fig. 10 where the six small circles represent the 6 thermocouples (e.g., 3 distal and 3 proximal).
• the inner circle represents the electrode assembly 19 and the outer ring represents the tip electrode sides. Any change in the desired orientation of tip 13 (e.g., from a perpendicular orientation to the tissue 22), can result in temperature rise of the corresponding part of the electrode assembly 19, as indicated by the darker color in the lower quadrant.
• Fig. 11 provides a schematic overview of the subject study protocol of this disclosure, which is in Appendix 2 of priority application, United States Prov. App. No. 62/843,213 , and incorporated by reference in its entirety as if set forth verbatim herein. All patients considered for RF ablation procedure for drug refractory recurrent symptomatic PAF were evaluated in the study by the investigator or designated member of the research team for study eligibility per the protocol inclusion and exclusion criteria. Pre-procedure assessments were performed within 30-days prior to the index AF ablation procedure unless otherwise noted.
• the primary goal of the study was to demonstrate clinical safety and effectiveness when catheter 28 was used with the RF generator of this disclosure in the treatment of drug refractory symptomatic paroxysmal atrial fibrillation (PAF) during standard electrophysiology mapping and RF ablation procedures.
• PAF drug refractory symptomatic paroxysmal atrial fibrillation
• both endpoints must be statistically significant relative to their respective performance goals.
• the primary safety endpoint was the proportion of subjects with any Primary Adverse Event (PAE) occurring within 7 days of ablation procedure. The PAE rate was compared against a primary goal of 14%.
• the primary effectiveness endpoint of the study was the proportion of patients that were free from documented atrial arrhythmia (atrial fibrillation (AF), atrial tachycardia (AT), or atrial flutter (AFL)) episodes at Month 12 (that is, during the 9-month post-blanking period, i.e. Day 91-365).
• AF atrial fibrillation
• AT atrial tachycardia
• AFL atrial flutter
• the major secondary objectives of this study were to evaluate the incidence of (serious) adverse events during and after procedure up to 3 months following procedure, to evaluate Acute Procedural Success as defined by the % of subjects with electrical isolation of PVs (entrance block) at the end of the procedure, and the % of subjects with electrical isolation of PVs (entrance block) using QMODE+ as the only ablation strategy.
• Another secondary effectiveness endpoint was the % of subjects with electrical isolation of PVs (entrance block) at all power settings combined the % of subjects with electrical isolation of PVs (entrance block) after first pass isolation, after waiting period and adenosine challenge.
• Another secondary effectiveness endpoint was the % of subjects and % of PVs with touch-up (i.e.
• touch-up is used to remove ablation of acute reconnection) among all targeted veins and touch-up location.
• Another secondary effectiveness endpoint was the anatomical location of acute PV reconnection after first encirclement.
• Another purpose of this study was to compare the primary effectiveness of the catheter 28 to a pre-determined performance goal of 50%, which is indicated as the minimum acceptable success rate at 12 months for a paroxysmal AF population.
• the power control mode sometimes referred herein as QMODE
• QMODE The power control mode
• QMODE temperature control was used for all RF applications outside the PV ostia during the study ablation procedure.
• QMODE included either (a) 25-35W at a flow rate of milliliters/minute or (b) 36-50W at a flow rate of 15 milliliters/minute.
• QMODE is a relatively high flow rate starting up to minimal 2 seconds before the onset of RF energy delivery and maintaining this higher flow rate up to 4 seconds after termination of the energy application.
• QMODE+ was used as the primary mode for PVI. However, if the investigator deemed QMODE+ unable to achieve PVI, the catheter 28 in QMODE was used to complete the procedure.
• the catheter 28 was assessed for clinical safety and performance according to following objectives: (1) Char/coagulum and steam pop rate of catheter 28 using its test ablation mode compared with conventional catheters using power control mode; (2) Lesion dimensions (max depth, max diameter and surface diameter) comparison between catheter 28 and control catheters; and (3) Ablation parameters were collected for analysis for characterization purposes to understand the similarities and differences in their behavior when compared to control catheters: average power, maximum electrode temperature, Temperature Rise, Initial Impedance, Impedance Drop.
• test ablation mode e.g., nMARQ multichannel RF generator
• the overall safety and functional performance of catheter 28 using its test ablation mode was also compared to the Smart Touch SF control catheter (Control Catheter 1) being used in power control mode (i.e. Smart Ablate generator).
• the catheter 28 was assessed to (1) deliver RF energy at a target site; (2) demonstrate acute isolation of the pulmonary vein; (3) demonstrate clinically acceptable signal quality which was comparable to control; (4) pace from ring electrodes and microelectrodes during idle-state and during ablation; (5) provide significantly better temperature feedback during ablation than control catheter; (6) function effectively when used in conjunction with ancillary equipment (e.g., such as an RF generator, QDOT Dongle, CoolFlow pump and CARTO 3 mapping system).
• ancillary equipment e.g., such as an RF generator, QDOT Dongle, CoolFlow pump and CARTO 3 mapping system.
• test ablation mode e.g., high power, short duration such as approximately 90W/4s
• RF generator e.g., Smart Ablate RF generator
• the catheter 28 was assessed for safety and performance a test ablation mode with the following objectives being tested: (1) safety of catheter 28 using test ablation mode (e.g., char/coagulum and steam pop) compared with Control Catheter 1 using its power control mode); (2) lesion dimensions (max depth, max diameter and surface diameter) comparison between test and control catheters; and (3) average power, maximum electrode temperature, temperature rise, initial impedance, and impedance drop.
• test ablation mode e.g., char/coagulum and steam pop
• Lesion dimensions maximum depth, max diameter and surface diameter
• the ablation procedure utilized the herein described ablation modes (e.g. QMODE and QMODE+ temperature control modes) to treat subjects with PAF.
• the test ablation mode of QMODE+ for temperature control was used primarily for PVI.
• the power control mode of QMODE temperature control was used primarily for AF application outside the PV ostia and for touch-up of the PVI.
• Fig. 12 shows a table summarizing the equipment used in the study.
• Fig. 13 shows a table summarizing AADs and impact on primary effectiveness classification for the study of this disclosure.
• the study investigated Class I drugs (e.g., flecainide, propafenone, disopyramide, etc.) and Class III drugs (e.g., amiodarone, dronedarone, dofetilide, etc.
• Class I drugs e.g., flecainide, propafenone, disopyramide, etc.
• Class III drugs e.g., amiodarone, dronedarone, dofetilide, etc.
• the table of Fig. 13 shows corresponding status of primary effectiveness endpoints based on AAD therapy administered in the blanking and post-blanking periods.
• Fig. 14 shows a table summarizing ablation mode and flow rate settings during RF applications.
• the row with power settings of 90W corresponds to the test ablation mode.
• Temperatures displayed on the RF generator during the study did not necessarily represent tissue temperature or electrode tissue interface temperature.
• the irrigation pump associated with the investigated catheter 28 was configured to deliver a continuous infusion of 2 milliliters/minute of room temperature heparinized saline (1 u heparin/1 millileter saline) when not delivering RF energy. Increase the irrigation to high flow rate starting minimal 2 seconds before the onset of RF energy delivery.
• the recommended contact force working range was between 5 and 30g.
• the AF ablation procedures for this study in the test ablation mode followed the following sequence: (1) Diagnostic catheter placement; (2) Electrophysiology study (discretion of investigator); (3) Cardioversion if subject is in AF (discretion of investigator); (4) CARTO ® Respiratory Gating Mandatory (unless using Jet Ventilation); (5) Placement of esophageal temperature monitoring device; (6) Confirmation of ACT in ⁇ 350 sec. PRIOR to insertion of the catheter 28 into the left atrium and maintain throughout the procedure; (7) Transseptal puncture; and (8) A left atrial anatomical map is recommended required prior to an ablation procedure in the LA. An anatomical map was not required of triggers outside of the left atrium (e.g. SVC/CS etc.).
• the sequence could include (9) Introduction of the catheter 28, which could include the following steps: use the AUTOTAG feature in Carto to tag each QMODE+ ablation point after each application; at the new location ensure catheter stability before commencing RF application; a pre-ablation flow rate delay of minimal 2 seconds will occur before RF application; ablation via RF power application of up to 90W for up to 4 seconds (QMODE+); move the catheter to a new location ( ⁇ 4 millimeter) if clinically effective ablation is achieved; and QMODE+ used for full PV encirclement. If the investigator deemed QMODE+ unable to achieve PVI, the catheter 28 in QMODE was used to complete the procedure. Step (9) could also include continuing RF applications and catheter 28 movement until the circumferential PVI is completed.
• RF application was stopped immediately.
• the decision to interrupt RF power delivery at any time during ablation was guided by investigator judgment and the monitoring of ablation effectiveness parameters, including catheter movement, electrogram reduction and/or impedance changes.
• precautionary measures such as pacing maneuvers were used to evaluate proximity to the phrenic nerve.
• the sequence could also include (10) Left Atrial ablation and real time PV isolation; (11) a 20-minute waiting period post ablation before pacing procedure(s) and/or infusion of cardiac medications to induce AF/reconnection (e.g., Adenosine, Isoproterenol 2-20 microgram/minute); (12) Confirmation of entrance block in all targeted PVs by Lasso ® or PentaRay ® ; and (13) conduct fluoroscopic evaluation of the diaphragm.
• AF/reconnection e.g., Adenosine, Isoproterenol 2-20 microgram/minute
• Fig. 15 shows a table summarizing the required schedule for subject treatment and evaluations in the study of this disclosure.
• the numbered notes correspond as follows: (1) Initial ablation procedure should be done within 30 days of consent; (2) Collected to confirm no changes in medical history since last visit; (3) AEs collected once consent has been signed Collected to confirm no changes in medical history since last visit; (4) If AE results in Hospitalization health economic data collection was required; (5) Quality of life tools (AFEQT); (6) Pregnancy test must be done on pre-menopausal women only, within 24 hours of the procedure; (7) Subjects should undergo imaging for the presence of LA Thrombus; (8) Imaging TTE to determine the atrial size (if the subject has undergone an imaging procedure within the last 6-months where the atrial size was assessed, the pre-procedure imaging assessment is not required); (9) Post procedure all Subjects will undergo a TTE procedure to assess the pericardium for pericardial effusion and/or pericarditis; (10) Concomitant medications: only cardiac
• the patient should also have a formal neurological consult and examination with appropriate imaging (i.e., DW-MRI), used to confirm any suspected diagnosis of stroke; (19) All subjects who undergo a repeat ablation procedure during blanking period with the catheter 28 will suggestive of PV stenosis or are in the CT/MRA PV Analysis procedure.
• appropriate imaging i.e., DW-MRI
• an "adverse event” was considered any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) occurring during a clinical study, whether or not related to the study device or ablation procedure.
• adverse events were deemed as occurring according to the following: event is vascular, cardiovascular, or neurologic in nature; the event is a serious adverse event; causality is related to catheter 28 and its ablation procedure; or unknown in nature.
• Figs. 16 , 17 , 18 , and 19 show summarize primary adverse events as determined in the study of this disclosure.
• a primary AE according to the study was one of the events listed in Figs. 16-19 that occurred within seven (7) days following an AF ablation procedure with the catheter 28 when used with the RF generator described herein, except atrio-esophageal fistula and PV stenosis, which may also be considered as primary adverse events if occurring greater than seven (7) days and up to 90 days post the ablation procedure.
• a serious adverse event (SAE) in the study was considered any event that meets one or more of the following criteria: Lead to a death; Lead to a serious deterioration in the health of a subject that resulted in a life-threatening illness or injury or a permanent impairment of a body structure or a body function; Required in-patient hospitalization or prolongation of existing hospitalization; or Resulted in medical or surgical intervention to prevent permanent impairment to body structure or a body function; Lead to fetal distress, fetal death or a congenital abnormality or birth defect.
• Fig. 20 is a table summarizing intensity or severity according to the study of this disclosure, whereby intensity or severity of AEs is defined. Intermittent AEs were classified according to their greatest severity. A continuous AE that changes severity was reported as a new AE.
• W Power range
• Procedural data collection was done through anonymized (or de-identified) generator files, anonymized (or de-identified) CARTO ® data files, procedural worksheets and subject medical files. Documentation of procedural data was kept in the subject's CRF, anonymized (or de-identified) back-up generator files and back-up CARTO ® data files for study analysis.
• RF application-mode per lesion QMODE+/QMODE/other
• Number of RF applications with Catheter 28 total/ QMODE+/QMODE
• Duration of RF applications with Catheter 28 total/ QMODE+/QMODE and with non-study catheter
• PVI ablation time time between first RF application and last RF application on a PV before isolation confirmed and circumferential ablation achieved
• Subject PVI ablation time time between first RF application and last RF application before all PVI complete
• Subject total ablation time time between first RF application and last RF application in a subject
• Ablation parameters per RF application location, temperature, impedance, power, contact force, RF duration, ablation index, lesion information on CARTO ® ; Ablation number on the generator for first RF application and last RF application per target (left PV targets, right PV targets and for targets outside the PV area); Ablation parameters for touch
• NIH Stroke Scale was administered by certified healthcare provider done prior to discharge.
• Other events prior to discharge included detecting occurrence of arrhythmias, a electrocardiogram (12-Lead ECG), and transthoracic echocardiogram (TTE), for evaluation pericardium for possible pericardial effusion and/or pericarditis.
• Cardiac-related concomitant medications such as AADs, anticoagulation regimen, etc.
• Cardiac-related concomitant medications prescribed since the ablation procedure till the end of follow-up were recorded, including the type and name of the medication, associated indications, starting and ending dates of the prescriptions, etc.
• Fig. 21 is a table summarizing AE outcomes as assessed in the study of this disclosure.
• Fig. 22 is a graph summarizing patient characteristics and medical history in the study of this disclosure.
• Fig. 23 is a graph summarizing acute pulmonary vein reconnection in the study of this disclosure.
• Fig. 24 is a graph summarizing primary adverse events in the safety population of the study of this disclosure.
• Fig. 25 is a graph summarizing procedural parameters in the study of this disclosure. As shown, the total procedure time, which was understood as the time of first puncture until the time of last catheter removed, including a 20-minute waiting time and the adenosine or isoproterenol challenge, was 105.2 ⁇ 24.7 minutes (range 68.0-177.0 minutes).
• mapping time was 9.5 ⁇ 5.3 minutes
• fluoroscopy time was 6.6 ⁇ 8.24 minutes
• total PV ablation time was 44.3 ⁇ 22.4 minutes
• total ablation time (from the time of the first radiofrequency application to the time of the last radiofrequency application) was 46.0 ⁇ 21.3 minutes
• left atrial dwell time time from catheter insertion in the left atrium until removal from the left atrium) was 81.7 ⁇ 20.2 minutes.
• the volume of fluid delivered by the ablation catheter was 382.4 ⁇ 299.1 mL.
• Fig. 26 is a graph summarizing procedural outcomes in the study of this disclosure. As can be seen, the procedural outcomes of catheter 28 as evaluated in the study are substantially improved over other previous multicenter studies. Key procedural parameters are shown for both the study, as well as previous multicenter studies: the THERMOCOOL AF trial which investigated a saline-irrigated radiofrequency ablation catheter, the SMART-AF trial which investigated a saline-irrigated force-sensing ablation catheter, and the SMART-SF trial which investigated a force-sensing ablation catheter with enhanced saline irrigation.
• the THERMOCOOL AF trial which investigated a saline-irrigated radiofrequency ablation catheter
• the SMART-AF trial which investigated a saline-irrigated force-sensing ablation catheter
• the SMART-SF trial which investigated a force-sensing ablation catheter with enhanced saline irrigation.
• Figs. 27A- 27B are tables summarizing comparative procedural outcomes between the catheter of this disclosure and prior clinically approved devices.
• the catheter 28 of this disclosure registered a total mean fluid delivered as 382.4 mL, which was approximately a 57.4% improvement (i.e. ⁇ 898.4 mL) over Smart Touch SF, approximately a 79.7% improvement (i.e. ⁇ 1879.6 mL) over Smart Touch AF, and approximately a 57.4% improvement (i.e. ⁇ 898.4 mL) over THERMOCOOL.
• the catheter 28 of this disclosure registered a mean total procedure time of approximately 105.2 minutes, which was approximately a 41.9% improvement (i.e. ⁇ 181.1 minutes) over Smart Touch SF, approximately a 52.8% improvement (i.e. ⁇ 222.7 minutes) over Smart Touch AF, and approximately a 49.9% improvement (i.e. ⁇ 210.1 minutes) over THERMOCOOL.
• the catheter 28 of this disclosure registered a mean total ablation time of approximately 46 minutes, which was approximately a 55.9% improvement (i.e. ⁇ 104.3 minutes) over Smart Touch SF, approximately a 62.1% improvement (i.e. ⁇ 121.5 minutes) over Smart Touch AF, and approximately a 58.3% improvement (i.e. ⁇ 110.3 minutes) over THERMOCOOL.
• the catheter 28 of this disclosure registered a mean total fluoroscopy time of approximately 6.6 minutes, which was approximately a 64.5% improvement (i.e. ⁇ 18.6 minutes) over Smart Touch SF, approximately a 84.1% improvement (i.e.
• catheter 28 of this disclosure registered a mean total RF ablation time of approximately 8.1 minutes, which was approximately a 83.6% improvement (i.e. ⁇ 49.5 minutes) over Smart Touch SF, approximately a 86.6% improvement (i.e. ⁇ 60.6 minutes) over Smart Touch AF. No prior known numbers were known regarding total RF ablation time for THERMOCOOL. Compared with previous studies using CF and non-CF catheters, catheter 28 clearly demonstrated substantially shorter total procedure, ablation, fluoroscopy, and radiofrequency application times, and less irrigation fluid load.
• Fig. 28 is a table summarizing results for ablations by setting on all locations of the study.
• Fig. 29 is a table summarizing results for ablations by setting on all locations of the study.
• the tables shows information related to first pass isolation versus acute reconnection in the test ablation mode with catheter 28 during the procedure of the study.
• the primary effectiveness endpoint (PVI confirmed after adenosine or isoproterenol challenge) was achieved using catheter 28 in all patients. Of note, in 78.8% (41/52) of cases, PVI was achieved using the test ablation mode only. In 26.9% (14/52) of patients and 5.0% (22/444) of veins, PV reconnection after adenosine/isoproterenol prompted additional lesions, the majority posteriorly. The original lesions were created with a combination of test ablation and standard ablation in 5 veins and with test ablation only in the other 17 veins showing acute reconnection. There were no applications placed with a non-study catheter. At the 3-month follow-up visit, 49 patients (94.2%) were in sinus rhythm, while two patients were in AF and one was in atrial flutter.
• SCLs were found in six patients (6/51, 11.7 %)).
• Four of these patients were on uninterrupted anticoagulation for at least 3 weeks before ablation, one patient was on warfarin that was interrupted the day before the procedure, and one was not using anticoagulation therapy.
• All lesions were classified as asymptomatic cerebral emboli, given the absence of clinical or neurologic deficits (as assessed by NIHSS, mRS, and MoCA).
• lesions were resolved by 1 month. While the reported incidence in previous studies of post-ablation cerebral lesions varies widely, these lesions are typically not associated with neurologic deficits, and most disappear on repeat MRI after 1 to 3 months post-ablation.
• Acute procedural success (defined as confirmation of entrance block in all treated PVs) was achieved in all 52 patients who underwent ablation. Only two PAEs were reported (a pseudoaneurysm and an asymptomatic thromboembolism); there were no reported deaths or instances of atrioesophageal fistula, stroke/cardiovascular accident, transient ischemic attack, PV stenosis, phrenic nerve paralysis, or cardiac tamponade.
• the overall incidence of coagulum observed with the catheter 28 in test ablation mode was shown to be clinically similar Control Catheter 1 and significantly less compared to Control Catheter 2.
• the overall incidence of steam pops observed with the catheter 28 in test ablation mode was clinically similar compared to Control Catheters 1 and 2.
• the lesion characteristics were clinically similar between the catheter 28 and the control catheters.
• the overall performance of catheter 28, in the test ablation mode was clinically similar or better compared to the Control Catheters 1 and 2 in power control ablation mode.
• the maximum ablation parameters identified for catheter 28, in the test ablation mode have been tested and assessed to be both clinically safe and clinically effective based on the results of this study.
• the catheter 28 when used with its test ablation mode was able to produce clinically effective electrogram signal attenuation and clinically equivalent to or better lesions as compared to the Control Catheter 1 in all four cardiac chambers.
• the generator used in connection with the catheter 28 was also shown to be able to successfully modify the irrigation flow rate based on catheter 28 electrode temperature response and power settings to maintain temperature limit when used in the test ablation mode.
• the catheter 28 with test ablation mode using the temperature target and flow rate settings was shown to satisfy all acceptance criteria.
• the overall functionality and the clinical safety of the catheter 28 with test ablation mode proved to be clinically equivalent to or better than that of Control Catheter 1.
• catheter 28 of this disclosure was evaluated with temperature-controlled 90W-4 second ablation mode that was applied at the thigh muscle and beating heart models in six (6) canines with an average weight of about 21.9 kilogram, as shown in Fig. 30A .
• an optical temperature sensor was placed into the thigh muscle of each patient at about a 3mm deep under the catheter tip to compare tissue temperature trend and heating pattern at single and double ablations as shown in Fig. 30B .
• the lesion depth was measured according to RF applications.
• a RA linear lesion integrity and any gaps between lesions were tested and examined in canine beating hearts using different sizes of lesion tag.
• 90W-4S created a continuous and transmural linear lesion line at the atrial wall with minimal over-lapped lesions. Consecutively overlapped 90W-4S applications applied intentionally created deeper lesions.
• Fig. 32 depicts a graphical overview of one method 3200 according to this disclosure.
• the method 3200 can include 3210 selectively positioning a diagnostic catheter at a treatment site in the vasculature; 3220 selectively positioning an ablation catheter system according to any previous claim at the treatment site; 3230 performing PVI by ablating tissue at the treatment site with the ablation catheter system; and 3240 clinically improving, by the ablation catheter system, total fluid delivered by the ablation catheter system and via intravenous line during the ablation procedure.
• Fig. 33 depicts a graphical overview of one method 3300 according to this disclosure.
• the method 3300 can include 3310 inserting an ablation catheter system according to any preceding claim to a treatment site comprising cardiac tissue, the system comprising at least one electrode and at least one sensor into the body in proximity; 3320 ablating the cardiac tissue with the ablation catheter system; and 3330 achieving complete pulmonary vein isolation, by the ablation catheter system, for all patients of a predetermined patient population suffering from PAF.
• Fig. 34 depicts a graphical overview of one method 3400 according to this disclosure.
• the method 3400 can include 3410 inserting an ablation catheter system according to any preceding claim into a body of a living subject; 3420 urging the ablation catheter system into contact with a cardiac tissue in the body; 3430 generating ablative energy at a power output level at a level of current; 3440 transmitting the generated energy into the tissue via the ablation catheter system; 3450 ablating the cardiac tissue with the ablation catheter system; and 3460 clinically improving, by the ablation catheter system, safety and effectiveness resulting in approximately at least 80% less RF ablation time compared to ablation time of a previous clinically approved catheter system for PAF.
• Fig. 35 depicts a graphical overview of one method 3500 according to this disclosure.
• the method 3500 can include 3510 selectively positioning a diagnostic catheter at a treatment site in the vasculature; 3520 selectively positioning an ablation catheter system according to any previous claim at the treatment site; 3530 performing PVI by ablating tissue at the treatment site with the ablation catheter system; and 3540 clinically improving, by the ablation catheter system, safety and effectiveness for PAF with a contact force between the ablation catheter system and a target site working ranging between approximately 5 - 30 grams.
• Fig. 36 depicts a graphical overview of one method 3600 according to this disclosure.
• the method 3600 can include 3610 inserting an ablation catheter system according to any preceding claim to a treatment site comprising cardiac tissue, the system comprising at least one electrode and at least one sensor into the body in proximity; 3620 ablating the cardiac tissue with the ablation catheter system; and 3630 achieving clinically improved safety and effectiveness for PAF with substantially shorter total procedure, ablation, fluoroscopy, and radiofrequency application times.
• Fig. 37 depicts a graphical overview of one method 3700 according to this disclosure.
• the method 3700 can include 3710 inserting an ablation catheter system according to any preceding claim into a body of a living subject; 3720 urging the ablation catheter system into contact with a cardiac tissue in the body; 3730 generating ablative energy at a power output level at a level of current; 3740 transmitting the generated energy into the tissue via the ablation catheter system; 3750 ablating the cardiac tissue with the ablation catheter system; and 3760 achieving, by the ablation catheter system, zero incidence of steam pop occurrence in both left and right atrial ablations using the ablation catheter system at a predetermined irrigation fluid rate and power setting that includes 90W.
• Fig. 38 depicts a graphical overview of one method 3800 according to this disclosure.
• the method 3800 can include method 3810 selectively positioning an ablation catheter system at a treatment site; and 3820 ablating tissue at the treatment site with the ablation catheter system using a power setting of approximately 90W applied to tissue for approximately four (4) second increments with a break period of approximately 4 seconds between applications.
• Fig. 39 depicts a graphical overview of one method 3900 according to this disclosure.
• the method 3900 can include 3910 delivering an ablation catheter system to a treatment site comprising cardiac tissue, the system comprising at least one electrode and at least one sensor in proximity with the other; 3920 ablating cardiac tissue with the ablation catheter system at a predetermined irrigation fluid rate and power setting comprising approximately 90W; and 3930 achieving approximately zero incidence of steam pop occurrence in both left and right atrial ablations and complete pulmonary vein isolation, by the ablation catheter system, for all patients of a predetermined patient population suffering from PAF.

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